U.S. EPA Announces Policy Changes to TSCA Chemical Risk Evaluations

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July 7, 2021Soraya VargasBlog

On 30 June 2021, the U.S. Environmental Protection Agency (EPA) announced that it would implement important policy changes surrounding risk evaluations issued under the Toxic Substances Control Act (TSCA) by the prior administration, as well as the next steps for the first 10 chemicals to undergo risk evaluation.

Verisk 3E Review 

The first 10 chemicals for which risk evaluations were released under the previous administration are:

  • 1,4-Dioxane
  • 1-Bromopropane
  • Asbestos (part 1: chrysotile asbestos)
  • Carbon tetrachloride
  • Cyclic aliphatic bromide cluster (HBCD)
  • Methylene chloride
  • N-methylpyrrolidone (NMP)
  • Pigment violet 29
  • Tetrachloroethylene, also known as perchloroethylene
  • Trichloroethylene

The risk evaluations for these chemicals did not assess air, water, or disposal exposures to the general population because these pathways could already have been regulated under other EPA-administered statutes, such as the Clean Air Act, Safe Drinking Water Act, or Clean Water Act. However, the exclusion of certain pathways resulted in the inability to focus on possible exposures to potentially exposed or susceptible subpopulations, including fenceline communities (i.e., communities near industrial facilities).

In particular, the original risk evaluation and supplemental assessment for 1,4-dioxane did not evaluate the above factors. Thus, the EPA intends to re-open the risk evaluation for this substance to consider whether to include additional exposure pathways, such as drinking water and ambient air, as well as the conditions of use where this substance is generated as a byproduct. The EPA plans to invite public comment on any potential revisions to the 1,4-dioxane risk evaluation before finalizing them. 

For six of the 10 chemicals, the EPA plans to further examine whether the exclusion of certain exposure pathways might lead to a failure to identify and protect fenceline communities. The six chemicals are methylene chloride, trichloroethylene, carbon tetrachloride, perchloroethylene, NMP, and 1-bromopropane. 

If the EPA determines that there is no unreasonable risk to these communities, it intends to move forward to proposed risk management rulemakings. In the alternative, the EPA will conduct a more comprehensive exposure assessment of fenceline communities and will supplement the risk evaluation for the chemical in question with that new information. 

Later this year, the EPA plans to make these screening approaches and methods, as well as their application to one or more chemicals, available for public comment and have them peer reviewed by the Scientific Advisory Committee on Chemicals.

Use of Personal Protective Equipment

Data on violations of personal protective equipment (PPE) use have shown that PPE is not always provided to workers or worn properly, as the EPA assumed under the previous administration. The EPA is now revisiting this assumption in order to protect workers and address unreasonable risks during the risk management process. The first 10 risk evaluations, which include exposure analysis with and without PPE, do not need additional analysis.

However, this policy shift could alter some of the conclusions about risk for some conditions of use for six of the first 10 chemicals for which "no unreasonable risk” findings were made based on the use of PPE. In particular, this shift could impact conclusions about risk for some conditions of use for methylene chloride, 1-bromopropane, HBCD, NMP, perchloroethylene, and 1,4-dioxane. 

Chemicals Moving to Risk Management

The EPA has reviewed the risk evaluations issued for HBCD, PV29, and asbestos (part 1: chrysotile asbestos). Based on this review, the agency believes that the risk evaluations are likely sufficient to inform the risk management approaches being considered, and that these approaches will be protective. Moving forward, the agency intends to reissue the risk determinations that amend the approach to PPE and include a whole chemical risk determination for these three chemicals. In addition, the EPA is working expeditiously on risk management and believes the proposed rules for these three chemicals will likely be the first of the 10 to be ready for release. 

Whole Chemical Approach

The EPA had made separate unreasonable risk determinations for every condition of use of a chemical during the prior administration. For the first 10 chemicals under the TSCA and for any similar chemical that presents significant risks across many uses, the EPA will continue to assess and analyze each condition of use. Thereafter, the agency plans to make the determination of unreasonable risk just once for the whole chemical when it is clear the majority of the conditions of use warrant one determination. The EPA intends to withdraw the previously issued orders for those conditions of use for which no unreasonable risk was found for all of the first 10 risk evaluations. The EPA then intends to issue revised unreasonable risk determinations for these chemicals as a "whole substance." The agency will also seek public comment on this approach.

Verisk 3E Analysis 

Businesses that manufacture (including import) or sell any articles containing any of the 10 chemicals evaluated under the first 10 risk evaluations should be aware of the EPA's policy changes, as they may impact future compliance strategies.
More information on the TSCA risk evaluations can be found on the Chemicals Undergoing Risk Evaluation under TSCA website.  








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